The Role of Macrophage Activation in Lung Injury Following Ozone Exposure

Not Applicable

Recruiting

• Conditions: Air Pollution
• Interventions: Other: Clean Air; Other: Ozone

• Registration Number: NCT05794087
• Lead Sponsor: Rutgers, The State University of New Jersey

Brief Summary

The purpose of the study is to better understand the mechanisms of lung injury from ozone exposure. Subjects will participate in two exposure sessions: filtered air and 0.2 ppm ozone. The exposure visits will be at least 2 weeks apart. Subjects will be asked to produce sputum through coughing after each exposure. The samples will be analyzed for macrophage activity.

Detailed Description

Subjects will be asked to come to the Rutgers EOHSI clinical center (Piscataway, NJ) for 5 study visits. A physical exam to determine eligibility will be done at the first study visit. If the subject is healthy and able to produce a sputum sample, he/she will then be scheduled for 2 3-hour exposure visits, at least 2 weeks apart. One exposure will be to clean air and the other exposure will be to 0.2 ppm ozone. During the exposures, subjects will be requested to ride an exercise bicycle intermittently (approximately every 15 minutes). A follow-up visit for sputum collection will be scheduled either 24, 48, or 72 hours after each exposure visit. Blood and exhaled breath samples will also be collected at each visit.

Study Timeline

• Study Start: 2023-02-07
• Study First Submitted: 2023-02-10
• Status Verified: 2023-03
• Study First Submitted QC: 2023-03-20
• Study First Posted: 2023-03-31
• Last Update Submitted: 2023-06-08
• Last Update Posted: 2023-06-12
• Primary Completion: 2027-06-01
• Study Completion: 2027-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Vaccinated against COVID-19

Exclusion Criteria

• Cardiovascular disease
• Respiratory disease
• Recent (within 4 weeks) respiratory or COVID-19 symptoms
• Diabetes
• Pregnancy
• HIV Infection
• History of smoking within the past 5 years.
• Orthopedic or rheumatologic conditions which would interfere with cycle use
• Inability to produce a sputum plug at screening
• Daily use of antioxidant supplements, excluding those in a multivitamin. These supplements include Vitamin C or E, selenium, beta-carotene, lycopene, lutein, zeaxanthin and ginkgo biloba. Supplements taken less frequently but at least once a week will be reviewed by the principal investigator for eligibility determination.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Clean Air, Then Ozone	Ozone	Subjects will be exposed to clean air for 3 hours at the first exposure visit and 0.2ppm ozone for 3 hours at the second exposure visit. The visits will be at least 2 weeks apart.
Clean Air, Then Ozone	Clean Air	Subjects will be exposed to clean air for 3 hours at the first exposure visit and 0.2ppm ozone for 3 hours at the second exposure visit. The visits will be at least 2 weeks apart.
Ozone, Then Clean Air	Clean Air	Subjects will be exposed to 0.2 ppm ozone for 3 hours at the first exposure visit and clean air for 3 hours at the second exposure visit. The visits will be at least 2 weeks apart.
Ozone, Then Clean Air	Ozone	Subjects will be exposed to 0.2 ppm ozone for 3 hours at the first exposure visit and clean air for 3 hours at the second exposure visit. The visits will be at least 2 weeks apart.

Primary Outcome Measures

Name	Time	Method
Metabolic activity of inflammatory cells in induced sputum	Within 3 days of exposure	The metabolic activity of inflammatory cells in sputum will be assessed by the measurement of ATP production. The measurement will be made on an Agilent Seahorse using a Mitoplate Assay.

Trial Locations

Locations (1)

Rutgers - EOHSI; 🇺🇸 Piscataway, New Jersey, United States